GDUFA and Self-Identification: What’s changing? (And What’s Not?)

02.9.2017 | Posted by Daniel Henrich

GDUFA, or the Generic Drug User Fee Amendments, were passed by Congress in 2012, with the purpose of “speed[ing] access to safe and effective generic drugs to the public and reduc[ing] costs to industry.” Among other things, the initiative authorized FDA to collect user fees from the generic companies to offset the increasing costs of reviewing generic drug applications and policing the industry.

GDUFA requires sites engaged in certain generic drug activities to self-identify annually prior to paying a user fee set by the agency.

In 2016, FDA began the process of reauthorizing GDUFA, with some changes built into the revised version, called GDUFA II.

GDUFA II — What’s changing…

FDA has updated the fee schedule for Fiscal Year 2018. GDUFA I required a fee to be paid by a facility when it was listed in an Abbreviated New Drug Application (ANDA), whether that ANDA had been approved or was still under review. GDUFA II, on the other hand, requires the fee to be paid only for applications that have been approved. Rather than a flat fee, GDUFA II adjusts the fee based on the company’s number of approved applications. Also, provision is made for contract manufacturers (CMOs) to pay a significantly reduced fee versus manufacturers who hold their own ANDAs.

FDA released a final guidance document in September, 2016 on the GDUFA Self-Identification submission. For industry members who have completed Self-ID submissions in the past, the process will be familiar:

Submission must be made in Structured Product Labeling (SPL) format

DUNS Numbers and FDA-issued Facility Establishment Identifiers (FEI) are required for each site listed in the submission

In addition to the points above, perhaps the most important thing to know about GDUFA Self-ID is that the reporting period remains unchanged—the submission must be made annually between May 1 and June 1. The data submitted is for the coming Federal Government fiscal year, which runs from October 1 to September 30. Submissions in May, 2017 are for FY2018.

There are preparations to make prior to being ready for the submission, so it’s not too early to start getting prepared.

Do you have other questions or need help starting your GDUFA Self-Identification submission? Contact Reed Tech to talk with an expert.